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Microsoft Word C039900e doc Reference number ISO 5834 1 2005(E) © ISO 2005 INTERNATIONAL STANDARD ISO 5834 1 Third edition 2005 06 01 Implants for surgery — Ultra high molecular weight polyethylene —[.]
INTERNATIONAL STANDARD ISO 5834-1 Third edition 2005-06-01 Implants for surgery — Ultra-highmolecular-weight polyethylene — Part 1: Powder form Implants chirurgicaux — Polyéthylène très haute masse moléculaire — Partie 1: Produits sous forme de poudre Reference number ISO 5834-1:2005(E) © ISO 2005 ISO 5834-1:2005(E) PDF disclaimer This PDF file may contain embedded typefaces In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy The ISO Central Secretariat accepts no liability in this area Adobe is a trademark of Adobe Systems Incorporated Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing Every care has been taken to ensure that the file is suitable for use by ISO member bodies In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below © ISO 2005 All rights reserved Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland ii © ISO 2005 – All rights reserved ISO 5834-1:2005(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part The main task of technical committees is to prepare International Standards Draft International Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights ISO shall not be held responsible for identifying any or all such patent rights ISO 5834-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials This third edition cancels and replaces the second edition (ISO 5834-1:1998), which has been technically revised ISO 5834 consists of the following parts, under the general title Implants for surgery — Ultra-high-molecularweight polyethylene: Part 1: Powder form Part 2: Moulded forms Part 3: Accelerated ageing methods Part 4: Oxidation index measurement method Part 5: Morphology assessment method © ISO 2005 – All rights reserved iii INTERNATIONAL STANDARD ISO 5834-1:2005(E) Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form Scope This part of ISO 5834 specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants It is not applicable to finished products Normative references The following referenced documents are indispensable for the application of this document For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (including any amendments) applies ISO 1628-3, Plastics — Determination of the viscosity of polymers in dilute solution using capillary viscometers — Part 3: Polyethylenes and polypropylenes ISO 3451-1, Plastics — Determination of ash — Part 1: General methods ISO 11542-1, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 1: Designation system and basis for specifications ISO 11542-2, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 2: Preparation of test specimens and determination of properties DIN 53474, Testing of plastics, rubber and elastomers — Determination of the chlorine content (Wickboldcombustion) Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11542-1 and ISO 11542-2 apply Classification, designation and coding The material shall be classified as Type 1, Type or Type as defined by the flow properties given in Clause and the ash/trace element contents given in 7.1 © ISO 2005 – All rights reserved ISO 5834-1:2005(E) Manufacturing requirements The material shall consist of a homopolymer prepared by the polymerization of ethylene The powdered material supplied for each order shall be identified by lot numbers NOTE “Lot” refers to the material for which testing has been carried out and for which discrete records are kept Flow properties Flow properties shall be determined by measuring either elongation stress or viscosity number When measured using the appropriate test method, as defined in Table 1, the minimum value of either the elongational stress or the viscosity number shall exceed the relevant value given in Table for each type of material Table — Flow properties — Minimum values Property Units Type Types and Test method according to subclause Elongational stress MPa 0,2 0,42 8.1 Viscosity number ml/g 2,000 3,200 8.2 NOTE 7.1 Compliance with either of the above test requirements indicates satisfactory polymer molecular mass Limits of contamination Ash and trace elements When measured using the appropriate test method, as defined in Table 2, the amounts of ash, titanium, aluminium, calcium and chlorine shall not exceed the relevant value given in Table for each type of material Table — Maximum ash and trace element content Maximum quantity permitted mg/kg Element Test method according to subclause Type Type Type 3a Ash 125 125 300 8.3 Titanium 40 40 150 8.4 Calcium 5 50 8.4 Chlorine 30 30 90 8.4 Aluminium 20 20 100 8.4 a Type polymer is no longer manufactured However, in order to cover existing supplies held in stockpile, this Type material is retained in this part of ISO 5834 until the next revision 7.2 Particulate matter When measured using the test method given in 8.5, there shall be no more than three particles of contaminant in Type or Type materials and not more than 25 particles of contaminant in Type materials (see Footnote to Table 2), per (300 ± 20) g tested © ISO 2005 – All rights reserved ISO 5834-1:2005(E) Test methods CAUTION — The UHMWPE powder, semi-finished and finished products for this application are not equipped with light stabilizers and should therefore be protected against the influence of ultraviolet radiation 8.1 Elongational stress The elongational stress shall be determined in accordance with ISO 11542-2 8.2 Viscosity number The viscosity number shall be determined in accordance with ISO 1628-3 using a 0,02 % solution by mass of the material in decahydronaphthalene (decalin) at 135 °C 8.3 Ash content The ash content shall be determined in accordance with ISO 3451-1 performing duplicate tests on each of two test specimens at (700 ± 50) °C The average of the results on the two test specimens shall not exceed the value given in Table 8.4 Trace elements The amounts of the trace elements shall be determined using the methods given in Table Table — Methods of test for trace elements Element Method of test Titanium Atomic absorption or emission spectroscopy Aluminium Atomic absorption or emission spectroscopy Calcium Atomic absorption or emission spectroscopy Chlorine Ion chromatography in accordance with DIN 53474 or equivalent 8.5 Particulate matter Mix each of four test portions of (75 ± 5) g of the moulding material with (400 ± 10) ml of propan-2-ol, in four 000 ml conical flasks Shake each flask until the powder is thoroughly dispersed Examine the flasks with normal or corrected vision no less than after cessation of shaking and count the number of particles that settle to the bottom of each flask Test certificate Each lot shall be supplied with a test certificate stating the results of the tests conducted and conformance with the requirements of this part of ISO 5834 The test certificate shall include the following information: a) test values obtained in Clauses and as appropriate; b) statement of powder type, i.e Type 1, Type or Type 3; c) lot number; d) date(s) of test © ISO 2005 – All rights reserved ISO 5834-1:2005(E) 10 Labelling Each package of moulding material shall be clearly marked with at least the following information: a) manufacturer's name or trademark; b) description of contents; c) lot number; d) mass of the contents; e) the number of this part of ISO 5834, i.e ISO 5834-1:2005 © ISO 2005 – All rights reserved ISO 5834-1:2005(E) ICS 11.040.40 Price based on pages © ISO 2005 – All rights reserved